Status:
COMPLETED
A Randomised, Single Centre, Double-Blind, Two-Period Crossover, Glucose Clamp Trial
Lead Sponsor:
Medical University of Graz
Conditions:
Diabetes, Type I
Eligibility:
All Genders
18-65 years
Phase:
PHASE1
Brief Summary
Clinical pharmacology trials investigating insulin detemir in subjects with type 1 diabetes have shown a prolonged and reproducible action profile of insulin detemir compared with NPH insulin and insu...
Detailed Description
Primary objective: The primary objective is to compare the pharmacodynamic response of insulin detemir and NPL insulin with respect to duration of action in a 32-hour euglycaemic glucose clamp experi...
Eligibility Criteria
Inclusion
- Inclusion Criteria:
- Informed consent obtained before any trial-related activities.
- Diagnosed with type 1 diabetes and treated with insulin
- Male or female subject between 18 and 65 years of age
- Body mass index between 18.0 and 32.0 kg/m2
- HbA1c (glycosylated haemoglobin A1c) ≤ 11%
- Fasting C-peptide ≤ 0.05 nmol/L
- Treatment with intensified insulin therapy or continuous subcutaneous human insulin or insulin analogue infusion (CSII)\] for at least 3 months.
- Exclusion criteria
- Known or suspected allergy to the trial products or related products,
- Previous participation (randomised) in this trial.
- The receipt of any investigational product within 3 months prior
- Clinically significant abnormal haematology or biochemistry screening tests
- Subject who is known to have hepatitis or who is a carrier of the Hepatitis B surface antigen (HBsAg) or Hepatitis C antibodies, or has a positive result to the test for HIV antibodies.
- Supine blood pressure at screening (after 5 min in the supine position) ≥ 180 mmHg for systolic and/or ≥ 100 mmHg for diastolic. This exclusion criterion also pertains to subjects being on antihypertensives.
- Clinically significant abnormal ECG at screening
- Subject who has donated blood in excess of 500 mL within the 9 weeks preceding screening.
- Significant history of alcoholism or drug/chemical abuse
- Smoker
- Subject with mental incapacity or language barriers
- Surgery or trauma with significant blood loss within the 9 weeks preceding screening.
- Subject with a history of or presence of cancer
- History of any illness or disease that, in the opinion of the Investigator might confound the results of the trial or pose additional risk in administering the trial product to the subject.
- Current systemic treatment with drugs that could interfere with glucose metabolism \[such as systemic corticoids and monoamine oxidase (MAO) inhibitors\] and/or pharmacokinetics.
- Subject who has proliferative retinopathy or maculopathy and/or severe neuropathy (in particular autonomic neuropathy)
- Any condition that would interfere with trial participation or evaluation of results, as judged by the Investigator and/or the sponsor.
- Female of childbearing potential who is pregnant, breast-feeding or intends to become pregnant or is not using adequate contraceptive methods
Exclusion
Key Trial Info
Start Date :
November 1 2008
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
December 1 2008
Estimated Enrollment :
30 Patients enrolled
Trial Details
Trial ID
NCT00810589
Start Date
November 1 2008
End Date
December 1 2008
Last Update
December 18 2008
Active Locations (1)
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1
Medical University Graz
Graz, Graz, Austria, 8036